FDA Eases Drug Shortage with Imports

After Pres. Obama ordered new measures to fight shortages of key drugs last October, the FDA has dramatically improved its management of such shortages, the agency asserted Tuesday.

For one thing, it is using its enforcement discretion to allow imports of the chemotherapy agent Lipodox, an otherwise unapproved form of liposomal doxorubicin, as an alternative to the approved product Doxil.

And the agency is taking additional steps to beef up stocks of preservative-free methotrexate, another cancer drug that has been in short supply recently. It has approved a new generic source, from APP Pharmaceuticals, which expects to begin shipments in four to six weeks and will continue producing the drug indefinitely.

Also, it persuaded an existing supplier, Hospira, to expedite shipment of 31,000 vials this week - "enough for more than one month's worth of demand," according to an FDA statement.

At an agency press briefing Tuesday, Hospira CEO Michael Ball said the company would be shipping another 34,000 vials next week and 55,000 more in mid-March. He said these shipments would not only end the shortage of preservative-free methotrexate but will also provide a cushion against future supply disruptions.

FDA Commissioner Margaret Hamburg, MD, said, "Prevention of drug shortages must be a priority. And it is."

Len Lichtenfeld, MD, deputy chief medical officer of the American Cancer Society, agreed that the agency had made meaningful progress in combating drug shortages.

"The announcement today is a major step - I'll say major steps forward," he said at the briefing.

Following Obama's Oct. 31 order, which directed the agency to deal more aggressively with supply interruptions for critical drugs, the FDA hired additional staff in its shortages unit, which now boasts 11 full-time employees.

Capt. Valerie Jensen, RPh, the unit's associate director, said that when the agency learns that a supplier may have to stop shipping an important product, her staff reaches out to other companies making the same drug to urge them to ramp up production.

If that fails, the FDA contacts other domestic firms with the technical capacity to produce the drug, as well as foreign companies that produce the drug but do not have the necessary approvals to sell it in the U.S.

The agency pursued all of those avenues in coping with the Doxil and preservative-free methotrexate shortages, according to Hamburg and representatives of Hospira and APP Pharmaceuticals who spoke at the press briefing.

In the case of methotrexate, the FDA contacted Hospira months before production was halted at a Bedford Laboratories factory that had been the drug's single largest source.

The agency also fast-tracked APP's approval to produce the drug.

For liposomal doxorubicin, the FDA has granted temporary approval to Sun Pharma Global and its authorized distributor, Caraco Pharmaceutical Laboratories, to import Lipodox, after determining that the product's manufacture meets U.S. standards. The agency said it believed Sun Pharma could fully meet patient needs for liposomal doxorubicin.

Doxil was in shortage because the only U.S.-authorized producer was Janssen Biotech, which in turn had contracted its manufacture to Bedford Laboratories' Ben Venue factory.

The agency said it has averted 114 shortages since Oct. 31 and 195 shortages in all of 2011.

On Tuesday, the agency also released a draft guidance for manufacturers spelling out requirements for mandatory and voluntary notifications of drug supply interruptions that could create shortages.

The guidance "clearly describes for industry what, when, how, and why they should notify the FDA when an issue could lead to a product shortage or disruption in supply," Hamburg said.

"The data is [sic] clear that early notification has a significant and meaningful impact on drug shortages," she said.

She also called on Congress to enact pending legislation that would expand the agency's authority to prevent and rectify drug shortages.

Representatives of the oncology community at the press briefing echoed that sentiment.

Michael Link, MD, president of the American Society of Clinical Oncology, urged that permanent solutions to the growing shortage problem be put before Congress within 60 days.

He noted that the shortages of numerous oncology drugs were not only a problem for patients - it's "unimaginably painful" to tell patients that a drug they need is unavailable, he said - but the shortages had also forced delays and even cancellations of some clinical trials.

Peter Adamson, MD, of the Children's Oncology Group, wanted to put Congress on an even tighter deadline - four weeks to enact legislation. That's how long it takes to induce an initial remission in a child with acute lymphoblastic leukemia, he explained, arguing that passing a bill should not be more difficult.

Obama had also ordered the Justice Department to look into potential cases of drug hoarding and price-gouging by distributors. However, no announcements of progress on that front have been forthcoming.

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